E7-14889. Explanatory Document to the September 2005 Draft North American Free Trade Agreement Standard Operating Procedure for Determining Pesticide Maximum Residue Limits; Notice of Availability

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

EPA is seeking public comment on the document entitled Statistical Basis of the NAFTA Method for Calculating Pesticide Maximum Residue Limits from Field Trial Data available at http://www.pmra-arla.gc.ca/​english/​pdf/​nafta/​docs/​nafta_​mrls-e.pdf. Although Canada’s Management Regulatory Agency (PMRA) is also accepting comments, EPA and PMRA will be jointly responding to comments submitted to either agency. The document was prepared by the NAFTA MRL Harmonization Working Group (a group comprised of United States and Canadian governments, created to develop a coordinated pesticides regulatory framework among North American Free Trade Agreement (NAFTA) partners). The document provides additional technical and explanatory material for a standard operating procedure (SOP) previously released by Canada’s PMRA for public comment in September 2005. The document currently open for public comment supports the September 2005 draft SOP that is intended for use by residue chemistry reviewers in the United States and Canada to ensure that the same or similar residue chemistry data sets will result in the same or similar recommendation for maximum residue limit (MRL) levels for pesticide residues on food and feed commodities by each agency. The goal for this method is to minimize trade barriers of pesticide treated commodities between the United States and Canada.

DATES:

Comments must be received on or before August 31, 2007.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2007-0632, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-line instructions for submitting comments.
• Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
• Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket’s normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is [phone].

Instructions: Direct your comments to docket ID number EPA-HQ-OPP-2007-0632. EPA's policy is that all comments received will be included in the docket without change and may be made available on-line at http://www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or e-mail. The regulations.gov website is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.

Docket: All documents in the docket are listed in the docket index available in regulations.gov. To access the electronic docket, go to http://www.regulations.gov, select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov website to view the docket index or access available documents. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is [phone].

FOR FURTHER INFORMATION CONTACT:

Philip Villanueva, Health Effects Division (7509P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: [phone]; e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by this action if you are engaged in pesticide and other agricultural chemical manufacturing. Potentially affected entities may include, but are not limited to:

• Pesticide and other agricultural chemical manufacturing (NAICS code 325320) e.g., individuals or entities engaged in activities related to the registration of a pesticide product.

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

1. Submitting CBI. Do not submit this information to EPA through regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comments. When submitting comments, remember to:

i. Identify the document by docket ID number and other identifying information (subject heading, Federal Register date and page number).

ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.

iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.

iv. Describe any assumptions and provide any technical information and/or data that you used.

v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.

vi. Provide specific examples to illustrate your concerns and suggest alternatives.

vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

viii. Make sure to submit your comments by the comment period deadline identified.

II. What Action is the Agency Taking?

EPA is seeking public comment on the document entitled Statistical Basis of the NAFTA Method for Calculating Pesticide Maximum Residue Limits from Field Trial Data. The document, prepared by the NAFTA MRL Harmonization Working Group, serves as an added explanatory document to Canada’s PMRA and EPA’s OPP September 2005 draft document entitled Guidance for Setting Pesticide Maximum Residue Limits Based on Field Trial Data which is available at http://www.pmra-arla.gc.ca/​english/​pdf/​pro/​pro2005-04-e.pdf. The SOP includes procedures for using the companion “NAFTA MRL calculator,” the Microsoft Excel® spreadsheet that incorporates the decision algorithm and automates the statistical calculations as outlined by the SOP. The NAFTA MRL calculator can be downloaded from the PMRA website (http://www.pmra-arla.gc.ca/​english/​pdf/​mrl/​method_​calc.xls). The September 2005 draft SOP is intended for use by residue chemistry reviewers in the United States and Canada to ensure that the same or similar data sets will result in the same or similar recommendation for MRL levels in each regulatory program. A 60-day comment period was opened for this by PMRA in September 2005 and is now closed. The comments received by PMRA were shared with EPA.

Upon the September 2005 release of the draft SOP, PMRA and EPA announced that an additional explanatory document would be published at a future date. This document is now available on the PMRA website (see http://www.pmra-arla.gc.ca/​english/​pdf/​nafta/​docs/​nafta_​mrls-e.pdf) and EPA is seeking comment on the statistical (and non-statistical) basis of the selected procedures and algorithms. More detailed statistical, simulation, and other support for the methods described in the September 2005 draft SOP are provided in this follow-on document which is intended to provide a permanent and enduring record of the rationale, reasoning, historical context, and technical/statistical support for the MRL estimation methodologies described and discussed in the September 2005 SOP.

Once the public comment period closes for this document, the statistical support document, the SOP and the associated MRL calculator will be modified as appropriate to address the comments from this current public comment period and the previous PMRA comment period for the draft SOP, and then reissued. We anticipate these documents will be released in final form in December 2007.

List of Subjects

• Environmental protection
• Administrative practice and procedure
• Agricultural commodities
• North American Free Trade Agreement (NAFTA)
• Pesticides and pests

Dated: July 26, 2007.

Debra Edwards,

Director, Office of Pesticide Programs.